The Effectiveness of Vestibulectomy

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya

ClinicalTrials.gov Identifier:

NCT00873301

First received: March 31, 2009

Last updated: March 29, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 31, 2009
Last Updated Date	March 29, 2012
Start Date ^ICMJE	January 2009
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 22, 2010)	pain [ Time Frame: 6 months following surgery ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: March 31, 2009)	pain [ Time Frame: 6 months following surgery ]
Change History	Complete list of historical versions of study NCT00873301 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 22, 2010)	sexual function [ Time Frame: 6 months afater surgery ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: March 31, 2009)	sexual function [ Time Frame: 6 months afater surgery ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effectiveness of Vestibulectomy
Official Title ^ICMJE	Not Provided
Brief Summary	Women with vulvodynia will fill out a questionnaire and undergo a gynecological examination before and 6 months after vestibulectomy. The investigators hypothesize that pain will decrease.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Vulvodynia
Intervention ^ICMJE	Procedure: vestibulectomy Evaluation of the outcome of vestibulectomy which is the treatment of vulvar vestibulitis
Study Arm (s)	Experimental: vulvodynia Intervention: Procedure: vestibulectomy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	40
Completion Date	February 2012
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: vulvodynia, scheduled for vestibulectomy
Gender	Female
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT00873301
Other Study ID Numbers ^ICMJE	JB 13-08-2008
Has Data Monitoring Committee	No
Responsible Party	Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya
Study Sponsor ^ICMJE	Western Galilee Hospital-Nahariya
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Western Galilee Hospital-Nahariya
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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